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EC number: 269-505-3 | CAS number: 68259-02-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 13 October, 1992 to 16 October, 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Guidelines followed
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Pentasodium 4-amino-6-[[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-2-sulphonatophenyl]azo]-3-[(2,5-disulphonatophenyl)azo]-5-hydroxynaphthalene-2,7-disulphonate
- EC Number:
- 269-505-3
- EC Name:
- Pentasodium 4-amino-6-[[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-2-sulphonatophenyl]azo]-3-[(2,5-disulphonatophenyl)azo]-5-hydroxynaphthalene-2,7-disulphonate
- Cas Number:
- 68259-02-9
- Molecular formula:
- C25H19ClN10O16S5.5Na
- IUPAC Name:
- pentasodium 4-amino-6-({5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-2-sulfonatophenyl}diazenyl)-3-[(2,5-disulfonatophenyl)diazenyl]-5-hydroxynaphthalene-2,7-disulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: Animal #1: Approximately 13 weeks; Animal #2 and #3: Approximately 12 weeks
- Weight at study initiation: 2419 to 2664 g
- Housing: Individually in labelled cages with perforated floors and equipped with an automatic drinking system (ITl, Bergen, The Netherlands)
- Diet: Standard laboratory rabbit diet (LKK-20, pellet diameter 4 mm, Hope Farms, Woerden, The Netherlands) approximately 100 g/d, ad libitum
- Water: Tap-water diluted with decalcified water, ad libitum
- Acclimation period: At least five days
ENVIRONMENTAL CONDITIONS
- Temperature: 21 °C
- Humidity: 55 %
- Air changes: Air-conditioned with 15 air changes/h
- Photoperiod: 12 h artificial fluorescent light/12 h dark
IN-LIFE DATES: From October 13, 1992 to October 16, 1992
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- other: the untreated flank of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 500 mg
VEHICLE
- The test substance was moistened with distilled water, immediately before application, to ensure close contact to the animal's skin. - Duration of treatment / exposure:
- 4 h
- Observation period:
- Up to 72 h (The skin reactions were assessed at approximately 45 min, 24, 48 and 72 h after the removal of the dressings and test substance)
- Number of animals:
- Three male animals.
- Details on study design:
- TEST SITE
- Area of exposure: Approx. 10x15 cm²
- Type of wrap if used: The test substance was applied using a moistened Scotchpak-non-woven patch mounted on Micropore tape (3M, St. Paul, U.S.A.). The contralateral flank was similarly prepared (but without test substance and vehicle) to act as a procedural control. The dressing was wrapped around the abdomen and secured with an elastic bandage (Coban, 3M, St. Paul, U.S.A.).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Removed at the end of the exposure period using a tissue moistened with tap water and subsequently a dry tissue.
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Scoring of erythema was difficult due to blue staining of the treated skin at all observations (i.e., 45 minutes, 24, 48 and 72 h)
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Scoring of erythema was difficult at 24 h due to blue staining of the treated skin by the test substance.
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Scoring of erythema was difficult at 24 h due to blue staining of the treated skin by the test substance.
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- The observed skin irritation consisted of very slight erythema in animal #2 1 h after exposure, which had resolved within 24 h. No skin irritation was observed in animal #1 and #3 during the study.
There was no evidence of a corrosive effect on the skin. - Other effects:
- Colouration: Blue staining of the treated skin by the test substance was observed, which made scoring of erythema difficult at the first two observations.
Body weights: The body weights and body weight gain in the animals were normal. Variation in body weight gain may be considered the result of treatment procedures.
Toxic symptoms/mortality: No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was considered to be a non-irritant to skin.
- Executive summary:
A study was performed to assess the skin irritation potential of the test substance (of ca. 100 % purity) in New Zealand White rabbits according to OECD Guideline 404 and EU Method B.4 in compliance with GLP.
500 mg of test substance were applied to a clipped skin area of 10 x 15 cm² on one flank of each animal under a 2 x 3 cm² gauze pad. The pad was allowed to remain in contact with the skin for 4 h. Animals were scored for irritation reactions after 45 minutes, and 24, 48 and 72 h. They were monitored daily for viability, mortality and clinical signs. Body weights were recorded pre-test and at study termination.
Blue staining of the treated skin by the test substance was observed, which made scoring of erythema difficult at 45 minutes and 24 h in 2/3 animals and in 1/3 animal at all observations. The observed skin irritation consisted of very slight erythema in 1/3 animal 45 minutes after exposure, which had resolved within 24 h. No skin irritation was observed in remaining animals. No signs of body weight variability, toxicity or mortality were observed in any animal during the study period.
Under the test conditions, the test substance was considered to be non-irritating to skin.
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